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Femoral Introducer Sheath and Hemostasis (FISH) Device 5, 6, and 8 French

by Morris Innovative Research, Inc.

PMA P050043

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P050043↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP050043 Date20 Aug 2007ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Device, hemostasis, vascular
PMA Number
FDA Product Code
MGB
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Femoral Introducer Sheath and Hemostasis (FISH) Device is a vascular hemostasis system designed for the closure of femoral artery access sites. It is indicated for use in patients who have undergone diagnostic procedures using 5, 6, or 8 French procedural sheaths to reduce the time required to achieve hemostasis and ambulation.

This device is manufactured by Morris Innovative Research, Inc. and has received FDA PMA authorization. It is intended for clinical use following diagnostic interventions to manage arterial access sites effectively.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the FISH device?

    The FISH device is intended for the hemostatic closure of femoral artery access sites, specifically to reduce the time required for hemostasis and patient ambulation following diagnostic procedures.

  • Which procedural sheath sizes are compatible with this device?

    The device is indicated for use in patients who have undergone diagnostic procedures utilizing 5, 6, or 8 French procedural sheaths.

  • Has this device received regulatory authorization?

    Yes, the Femoral Introducer Sheath and Hemostasis (FISH) Device has received FDA PMA authorization.